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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K241598
Device Name LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)
Applicant
Boston Scientific Corporation
Boston Scientific Corporation-
Urology and Pelvic Health Division
Marlborough,  MA  01752
Applicant Contact Matthew Minks
Correspondent
Boston Scientific Corporation
Boston Scientific Corporation-
Urology and Pelvic Health Division
Marlborough,  MA  01752
Correspondent Contact Matthew Minks
Regulation Number876.1500
Classification Product Code
FGB  
Date Received06/04/2024
Decision Date 07/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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